FDA Guidance Offers New Flexibility To Biotechs In Cell And Gene Therapy

By Meghan Hosely, Marketing Content Manager

New guidance was recently released by the Food and Drug Administration regarding cell and gene therapy products. The guidance addresses biotech companies’ interest in “umbrella” trials—trials designed to evaluate multiple investigational drugs administered as single drugs, or as combination drugs in a single disease population.

There are many potential benefits to the umbrella trial. Most important for sponsors—and the public eagerly awaiting new therapies—is the opportunity to reduce a therapy’s total development and review/approval time to market.

Explore the implications of this guidance and its recommendations for organizing and structuring investigational new drugs (INDs), submitting new information, and reporting adverse events (AEs) focused on cellular or gene therapies.